Job Title: Sr. Systems Engineer
Client Location: Bay Area, CA
Employment Category: Direct Hire
Max Base Salary Offering: $180,000.00
Benefits Offered: Medical - Dental - Vision - Retirement Savings - ESPP - Company Bonuses
Citizenship Requirement: Open Requirement
Onboarding Requirement: Background & Drug-Screen
Projected Start Date: ASAP
The Senior Systems Engineer in Human Factors will play a key role in the development of next-generation Neuromodulation systems by working cross-functionally with internal and external customers, to ensure human factors are a key consideration in every system design.
Essential Duties and Responsibilities:
- Perform human factors engineering across the product lifecycle including identification of customer user needs and use scenario, the definition of use specifications (user profiles, user environments), and user interface requirements.
- Generate deliverables needed to demonstrate compliance with ISO/IEC 62366, ANSI/AAMI HE75, and FDA Guidance for Human Factors and Usability Engineering
- Ensure the user interface for the entire system, including software, mechanical and electrical interfaces, as well as packaging, labeling, and manuals, are thoroughly evaluated by users from a human factors perspective.
- Work with R&D electrical, mechanical, software, and firmware engineers, to generate hardware and software prototypes for early usability and human factors evaluations.
Minimum Qualifications: (Knowledge, Skills, and Abilities)
- Degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, Systems Engineering, or equivalent.
- Master's degree with 6+ years' relevant experience; Bachelor's degree with 8+ years' relevant experience.
- Experience with development in a highly regulated industry such as medical device, defense, or automotive.
- Experience generating usability and human factors technical documentation including user needs, use specification, user interface specification, use scenarios, and user error analysis (uFMEA, critical task analysis).
- Degree required or equivalent years of experience may be substituted for the education requirement.
- Experience interacting with external end-users in a professional medical environment (physicians, nurses, patients)
- Outstanding communication and presentation skills (written and verbal).
- Demonstrates professionalism and maturity for interacting with end-users including patients and physicians.
- Exceptional ability to solicit unbiased feedback from internal and external customers.
Work Environment/Travel Requirements:
- Willingness to travel for usability and human factors studies, up to 25% of the time.
- Ability to work on multiple projects in a deadline-driven environment.
- Ability to provide creativity while solving complex problems without known solutions.